Comparison of one vs three week radiation for breast cancer
Phase 3
- Conditions
- Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast
- Registration Number
- CTRI/2021/09/036622
- Lead Sponsor
- AIIMS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
� Age 18 - 75 years
� Female patients
� Biopsy proven IDC (any grade)
� Stage: T1-4b; N0-3; M0
� LVSI/PNI-allowed
� ER/PR/Her2neu-Any
� Karnofsky performance score 70 and above
� Pulmonary function test-WNL
� 2DECHO-LVEF 50-60%
� The patient must sign an informed consent before entry into the study
Exclusion Criteria
� Age >75 years and <18 years
� Not a surgical candidate
� Previous history of radiotherapy
� Recurrent disease
� Patients with significant co-morbid condition
� History of previous malignancy
� KarnofskyPerformance score below 70
� Not compliant for regular follow up
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i) To compare Ipsilateral breast Tumor recurrence Free survival (IBTR)Timepoint: 5 years
- Secondary Outcome Measures
Name Time Method i) To compare Loco-regional recurrence free survival (LRRFS) <br/ ><br>ii) To compare photographic cosmetic outcome (one pre RT, one month after RT and then every six <br/ ><br>months for three years) <br/ ><br>ii) To assess QoL by EORTC QLQ-C30 and BR-23 questionnaires <br/ ><br>iii) To correlate neutrophil count, lymphocyte and CD4 count with RFSTimepoint: 5 years